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Solid nicotine-comprising dosage form with reduced organoleptic disturbance
专利权人:
MCNEIL AB
发明人:
HUGERTH ANDREAS,LINDELL KATARINA,NICKLASSON FREDRIK,THYRESSON KRISTINA
申请号:
NZ62667213
公开号:
NZ626672A
申请日:
2013.01.07
申请国别(地区):
NZ
年份:
2016
代理人:
摘要:
Disclosed is a solid pharmaceutical dosage form, wherein the dosage form is not a chewing gum and is an orally disintegrating tablet form that completely dissolves or disintegrates in the oral cavity, for the release of nicotine in the oral cavity, comprising: a) a core encapsulated by at least one film coating, wherein the core comprises: i. nicotine resin complex and ii. a mint or fruit flavour and iii. one or more sweetener selected from the group consisting of sorbitol, xylitol, mannitol, sucralose and isomalt, and where the core has a weight of from 50 to 2000 mg, wherein b) the film coating comprises i. at least one film-forming polymer being hydroxypropyl methylcellulose (HPMC), ii. a plasticizer being polyethylene glycol or triacetin and/or iii. surfactant being polyoxyethylene (20) sorbitan monooleate, and iv. at least one sweetener being sucralose or aspartame and at least one flavour being mint or fruit for reduction of one or more organoleptically disturbing sensations, and where the at least one film coating is devoid of nicotine and devoid of buffer and has a thickness of from 10 to 500 microns, preferably the core has a weight of 90-1200 mg, and the film coating has a thickness of from 30 to 150 microns. The dosage form may also comprise at least one further active pharmaceutical ingredient, such as a zinc salt or zinc complex.
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中国工程科技知识中心
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